Targeted cancer drug, lorlatinib (Lorviqua, Pfizer) was rejected by the National Institute for Health and Care Excellence (NICE) for treating relapsed anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) in adults.
In provisional guidance, NICE said it could not be certain whether the ALK tyrosine kinase inhibitor offered significant benefits over existing treatment options because of limitations in the data and how the treatments were compared.
Rose Gray, policy manager at Cancer Research UK, said the decision would be "hugely disappointing" for people with this type of lung cancer.
"Clinicians told NICE this drug could give patients longer before starting chemotherapy, as well as improving people's quality of life," she said.
An appraisal committee accepted there was some evidence to suggest that patients treated with lorlatinib might live longer than those treated with platinum doublet chemotherapy. Also, that those treated with lorlatinib could live longer and experience slower disease progression than those treated with atezolizumab (Tecentriq, Roche) in combination with bevacizumab (Avastin, Roche), carboplatin, and paclitaxel.
Cost-effectiveness Issues
Although lorlatinib met the criteria to be considered a life-extending treatment, its high cost was not a justifiable use of NHS resources, NICE decided.
The recommended dose is 100 mg taken orally once daily.
The list price for a pack of 30 tablets (100 mg) is £5283.00. However, an agreed discount would have applied if the treatment had won approval.
Lorlatinib did not meet NICE's criteria for inclusion in England's Cancer Drugs Fund because clinical trials are now complete and not expected to produce any new evidence on the drug's benefits.
"This makes it crucial NICE, NHS England, and the drug's manufacturer continue to work together before this decision is reviewed later this year, so patients have the best chance of accessing the drug as quickly as possible," Rose Gray said.
Consultation Period
Dr Sanjay Popat, consultant medical oncologist at the Royal Marsden Hospital, and professor at the Institute of Cancer Research, commented on Twitter: "Lorlatinib is an important drug for relapsed ALK+NSCLC. Am hoping there will be constructive dialogue between NICE and Pfizer to allow an agreement on price."
The manufacturer has until the consultation period ends on 18th February 2020 to offer further data or price concessions.
NICE guidance applies in England but is usually adopted in Wales and Northern Ireland.
